ESMO Congress 2026

FDA Approves Roche's Tecentriq as Adjuvant Therapy for Stage III dMMR Colon Cancer

The US FDA has approved Roche's Tecentriq (atezolizumab) and its subcutaneous formulation Tecentriq Hybreza (atezolizumab and hyaluronidase), each combined with fluoropyrimidine and oxaliplatin, as post-surgery adjuvant treatment for stage III mismatch repair-deficient (dMMR) colon cancer. Roche said this is the first immunotherapy adjuvant approval for stage III dMMR colon cancer in the US, based on data showing a 50% reduction in risk of disease recurrence or death.

FDA Approves Atezolizumab for dMMR Stage III Colon Cancer and Tucatinib for HER2-Positive Breast Cancer

On October 8, 2026, the FDA approved atezolizumab (Tecentriq, Genentech) combined with a fluoropyrimidine and oxaliplatin as adjuvant therapy for stage III mismatch repair-deficient (dMMR) colon cancer in adults and children aged 2 and older. In the same window, the FDA also approved tucatinib maintenance therapy for HER2-positive breast cancer. On the same day, China's CDE released two draft guidances for comment, covering GVHD clinical trials and nonclinical PK studies.

FDA Approves IV and Subcutaneous Tecentriq for Stage III dMMR Colon Cancer Adjuvant Therapy

On October 8, 2026, the FDA approved Genentech/Roche's atezolizumab (Tecentriq), given intravenously with fluoropyrimidine plus oxaliplatin chemotherapy, as adjuvant treatment after surgery for stage III mismatch repair-deficient (dMMR) colon cancer in adults and children aged 2 and older. The subcutaneous formulation Tecentriq Hybreza, atezolizumab with hyaluronidase-tqjs, was also approved with the same chemotherapy for patients aged 12 or older weighing at least 40 kg. These are Tecentriq's second US indication expansions this year, after its approval months earlier for Signatera ctDNA-positive muscle-invasive bladder cancer.

FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer

The FDA approved atezolizumab (Tecentriq, Genentech) in combination with a fluoropyrimidine and oxaliplatin on October 8, 2026, for adjuvant treatment of Stage III mismatch repair deficient colon cancer in patients two years of age and older, with the subcutaneous Tecentriq Hybreza approved for those 12 years and older weighing 40 kg or greater. In the ATOMIC trial of 711 adults and one pediatric patient, the hazard ratio for disease-free survival was 0.50 versus mFOLFOX6 alone, and median DFS was not reached in either arm. Reviews are ongoing at partner agencies under Project Orbis.

At-home subcutaneous atezolizumab for non-small cell lung cancer: a prospective, single-arm phase II feasibility study

At-home subcutaneous atezolizumab for non-small cell lung cancer: a prospective, single-arm phase II feasibility study

A prospective, single-arm phase II feasibility study enrolled five patients with NSCLC to assess the safety and feasibility of at-home subcutaneous atezolizumab (1,875 mg every 21 days). Of 70 treatment cycles, 65 injections (93%) were delivered on time. Home administration took a mean of 42.3 minutes versus 86.7 minutes in clinic. Two of five patients (40%) had adverse events, and mean patient satisfaction with administration was 3.3/4.

[Comment] Combining immunotherapy with stereotactic body radiation therapy in localised non-small-cell lung cancer

A comment published alongside The Lancet discusses the phase 3 SWOG/NRG S1914 randomised trial led by Megan E Daly and colleagues in the USA. The trial tested whether perioperative atezolizumab, given neoadjuvantly, concurrently and as adjuvant, with stereotactic body radiation therapy improves outcomes in high-risk, medically inoperable early-stage non-small-cell lung cancer. Its primary endpoint compares overall survival in 210 patients given atezolizumab plus SBRT versus 207 given SBRT alone.

Circadian timing of first-line chemoimmunotherapy is associated with survival in extensive-stage small cell lung cancer

Earlier infusions of first-line platinum-etoposide plus atezolizumab or durvalumab were linked to longer survival in 107 patients with extensive-stage small cell lung cancer. Those treated before the cohort median time of day of administration (11:54) had median PFS of 9.07 vs. 7.23 months and OS of 21.17 vs. 11.43 months, with adjusted HRs of 1.63 and 1.65 for later administration, and no difference in toxicity. The finding points to infusion timing as a modifiable factor that warrants prospective testing.

Incremental Predictive Value and Representation of Transcriptomic Features for Immunotherapy Response in Advanced Urothelial Carcinoma

Knowledge-guided tumor microenvironment gene-set features outperform data-driven transcriptome-wide gene selection for predicting atezolizumab response in advanced urothelial carcinoma. In 298 IMvigor210 patients, they improved AUPRC by 0.058 over clinical variables, but gains shrank to +0.011 beyond TMB and PD-L1, and data-driven selection was unstable (Jaccard 0.227) with AUPRC 0.150 lower. The pattern replicated in an external cohort (+0.128 vs +0.019).

Induction and consolidation atezolizumab with stereotactic body radiation therapy versus radiation alone in high-risk, early-stage non-small-cell lung cancer (SWOG/NRG S1914): a multicentre, open-label, superiority, phase 3, randomised controlled trial.

Atezolizumab in early triple-negative breast cancer: the randomized phase 3 NSABP B-59/GeparDouze trial.

Adding atezolizumab to neoadjuvant taxane-carboplatin-anthracycline chemotherapy did not significantly improve event-free survival in stage II-III triple-negative breast cancer, with an HR of 0.80 (95% CI, 0.62-1.03; P = 0.083) and a 4-year EFS difference of 3.3%. Prespecified subgroup analysis suggested benefit in patients with clinical lymph node involvement (P interaction = 0.039), and an exploratory mRNA subset analysis pointed to basal-like immune-activated tumors as potential responders. Immune-related adverse events occurred in 27.6% with atezolizumab versus 11.4% with placebo.

[Articles] Induction and consolidation atezolizumab with stereotactic body radiation therapy versus radiation alone in high-risk, early-stage non-small-cell lung cancer (SWOG/NRG S1914): a multicentre, open-label, superiority, phase 3, randomised controlled trial

Adding induction and consolidation atezolizumab to stereotactic body radiation therapy did not improve overall survival in patients with high-risk, inoperable, early-stage non-small-cell lung cancer in the SWOG/NRG S1914 phase 3 randomised trial. This was the first fully reported phase 3 cooperative group trial of immunotherapy in this setting, and the combination produced more grade 3 or higher adverse events than radiation alone. The results argue against adding atezolizumab to SBRT in this population.

Liver resection after atezolizumab and bevacizumab versus maintenance therapy for locally advanced hepatocellular carcinoma (TALENTOP): a multicentre, open-label, randomised, phase 3 trial.

Liver resection after response to atezolizumab plus bevacizumab prolonged time to treatment failure in advanced hepatocellular carcinoma with macrovascular invasion and no extrahepatic metastasis. In the phase 3 TALENTOP trial, 201 responders were randomised to surgery plus 12 months of the combination or maintenance therapy; median time to treatment failure was 20·4 versus 11·8 months (hazard ratio 0·60, p=0·015). Grade 3 or 4 treatment-related adverse events were more frequent with surgery (39% vs 21%).

Atezolizumab in early triple-negative breast cancer: the randomized phase 3 NSABP B-59/GeparDouze trial

Adding atezolizumab to neoadjuvant chemotherapy did not improve event-free survival in the phase 3 NSABP B-59/GeparDouze trial of patients with early-stage triple-negative breast cancer, missing its primary endpoint. Translational analyses identified tumor microenvironment-dependent determinants of response, indicating basal-like immune-activated tumors may respond to atezolizumab plus chemotherapy.

Consolidative Thoracic Radiotherapy With Atezolizumab Maintenance in ES-SCLC

Last poster session #AACR26 Check out spatial transcriptime analysis by @LFonkoua from phase II trial #HCC treated with combination radia...

Clinical Trial Results: Long-term Updates on Approved Immunotherapies

A record 265 clinical trial abstracts fed five minisymposia. The 'Updates in Anticancer Immunotherapies' session covered atezolizumab in alveolar soft part sarcoma: 54 patients enrolled as of June 2025, with responses lasting 10 to 69 months.